Hepatitis B, Chronic
Conditions
Brief summary
This study will evaluate the efficacy, safety, and tolerability of PEGASYS in participants with HBeAg-negative chronic HBV. The anticipated time on study treatment is 48 weeks, and the target sample size is 60 individuals.
Interventions
DRUGPeginterferon alfa-2a
180 uG in 0.5 mL solution administered once weekly for 48 weeks
Sponsors
Hoffmann-La Roche
Study design
Allocation
NON_RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 70 Years
Healthy volunteers
No
Inclusion criteria
* Adult participants 18-70 years of age * Positive test result for HBsAg for \>6 months * Naive to treatment for HBV * On liver biopsy, liver disease consistent with chronic HBV, with or without compensated cirrhosis
Exclusion criteria
* Co-infection with hepatitis A, C or D, or with Human Immunodeficiency Virus (HIV) * Decompensated liver disease * Hepatocellular cancer * Systemic anti-viral, anti-neoplastic, or immunomodulatory therapy less than or equal to 6 months before study drug * Medical condition associated with chronic liver disease
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Efficacy: Hepatitis B Virus - Deoxy ribonucleic acid (HBV-DNA) less than (<)20,000 Copies per milliliter (copies/mL) At End of Follow-Up | 72 Weeks |
| Alanine Transaminase (ALT) Normalization at the End of Follow-Up | 72 Weeks |
Secondary
| Measure | Time frame |
|---|---|
| Hepatitis B Virus (HBV) DNA Below the Limit of Quantification At the End of Follow-Up | 72 Weeks |
| HBV DNA Suppression <20000 Copies/mL at the End of Treatment | 48 Weeks |
| Alanine Transaminase (ALT) Normalization at the End of Treatment | 48 Weeks |
| Efficacy: Loss of Hepatitis B Virus Antigen ( HBsAg) and Seroconversion at End of Follow-Up | 72 Weeks |
Countries
Bulgaria
Outcome results
None listed